Pfizer, Merck KGaA’s Bavencio flops in ‘high-risk’ stomach cancer trial
November 28, 2017
By Neozene

Pfizer and Merck KGaA are working to carve out a niche for immuno-oncology drug Bavencio in a crowded field. But a failed phase 3 trial in advanced stomach cancer just dinged their ambitions. Tuesday, the companies said Bavencio (avelumab) failed to outperform physician’s choice of chemo at improving overall survival among third-line metastatic gastric or gastroesophageal junction adenocarcinoma patients. The trial enrolled 371 patients regardless of their PD-L1 expression levels. As the pair was quick to point out, third-line gastric cancer “is a particularly hard-to-treat and heterogeneous disease, and importantly, this

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Relax, pharma. Amazon’s eyeing medical and device sales before drugs
November 20, 2017
By Neozene

Industry watchers have been parsing Amazon’s every move to divine whether the company will upend pharma by moving into drug sales or distribution. But a new report says the tech and retail behemoth may go after a simpler market first. That would be medical devices and supplies, according to a note from Jefferies analysts. The company has told regulators it won’t “ship or store drugs,” Jefferies analysts wrote in a new investor note. But Amazon does intend to sell medical devices and supplies from fulfillment centers in Indiana, according to

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China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements
November 7, 2017
By Neozene

The China Food and Drug Administration (CFDA) has proposed exempting additional medium- and high-risk medical devices and in vitro diagnostic (IVD) devices from clinical trial requirements. CFDA’s proposed exemptions would amend Order 650 (links in Chinese), and apply to 48 Class II and III medical device product names, as well as several IVD product names. Earlier in 2017, the regulator proposed clinical trial exemptions for 22 Class II devices and six Class III devices; these additional proposed exemptions suggest ongoing attempts by CFDA to loosen some Chinese market access requirements

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